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Draeger Anesthesia Workstation Correction Expanded

[ Price : $8.95]

Draeger expands a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations u...

FDA Warns Pharmathen Over Sterility, Data Integrity Concerns

[ Price : $8.95]

FDA sends a Warning Letter to Greek contract manufacturer Pharmathen International citing significant GMP violations at its steril...

Panel to Weigh Favorable Data on Moderna's mRNA Flu Vaccine

[ Price : $8.95]

A 6/18 advisory committee meeting is set to review Moderna's investigational mRNA influenza vaccine as the agency posts a briefing...

FDA Delays Isotretinoin REMS Modifications

[ Price : $8.95]

FDA says there is an implementation delay for isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy modif...

Zoll Medical QSR, MDR Violations

[ Price : $8.95]

FDA warns Chelmsford, ME-based Zoll Medical about Quality System and Medical Device Reporting violations in its manufacturing of s...

Petition urges FDA to Ban Gadolinium MRI Contrast Agents

[ Price : $8.95]

A citizen petition urges FDA to impose an immediate moratorium on the use of gadolinium-based contrast agents in MRI scans.

FDA Authorizes Colorado Prescription Drug Importation Program

[ Price : $8.95]

FDA authorizes Colorado's prescription drug importation program, marking another step forward for state-led efforts to lower drug ...

FDA, MHRA Launch Liaison Program for Regulatory Cooperation

[ Price : $8.95]

FDA and the UK's Medicines and Healthcare products Regulatory Agency announce a new liaison program designed to strengthen collabo...

Jaypirca Combination Cuts Progression Risk by 45% in CLL Trial: Lilly

[ Price : $8.95]

Eli Lilly reports positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and ritux...

Plausible Mechanism Faces Challenges: Commentary

[ Price : $8.95]

Significant operational hurdles remain before FDA's Plausible Mechanism Framework can be broadly implemented, according to a comme...